Director of Regulatory Affairs Jobs in Irvine, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Associate Director, Regulatory Affairs
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA (19 miles from Irvine, CA)
- 11 hours ago
- Seal Beach, CA (19 miles from Irvine, CA)
- 11 hours ago
Job Summary: The Associate Director of Regulatory Affairs develops and executes global regulatory strategies to support product development, lifecycle management, and commercialization objectives....
In PersonDirector, Regulatory Affairs Devices and Combination Products
- AbbVie, Inc
- Irvine, CA
- 5 days ago
- Irvine, CA
- 5 days ago
Job Description The Director Regulatory Affairs, Device is responsible for combining knowledge of scientific, regulatory and business issues to support and drive strategy for regulatory submissions,...
In PersonRegulatory Affairs & Quality Assurance Manager
- University of California System
- Orange, CA (6 miles from Irvine, CA)
- 13 days ago
- Orange, CA (6 miles from Irvine, CA)
- 13 days ago
Overview Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The...
In PersonDirector, Regulatory Affairs Strategy
- Alcon
- Lake Forest, CA (10 miles from Irvine, CA)
- 17 days ago
- Lake Forest, CA (10 miles from Irvine, CA)
- 17 days ago
The Director, Regulatory Affairs Strategy (Management Path) is primarily responsible for directing product registration activities, providing strategic regulatory guidance, and leading negotiations...
In PersonManager, Regulatory Affairs THV
- Edwards Lifesciences
- Irvine, CA
- 30+ days ago
- Irvine, CA
- 30+ days ago
(e.g., ITA's, IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files) Provide guidance on regulatory requirements necessary for strategic and contingency planning...
In PersonProject Manager, Regulatory Affairs (VALVE)
- JENAVALVE TECHNOLOGY INC
- Irvine, CA
- 45+ days ago
- Irvine, CA
- 45+ days ago
Comprehensive knowledge of quality systems and relationship to business....
In PersonAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Irvine, CA
- 60+ days ago
- Irvine, CA
- 60+ days ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
Hybrid- iRhythm Technologies
- Orange, CA (6 miles from Irvine, CA)
- 90+ days ago
- Orange, CA (6 miles from Irvine, CA)
- 90+ days ago
System Monitoring the impact of changing global regulations on submission strategies & registrations Support external and internal audits Perform other regulatory-related duties as assigned....
In PersonDemographic Data for Irvine, CA
Moving to Irvine, CA? Find some basic demographic data about Irvine, CA below.
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Salary for Director of Regulatory Affairs Jobs in Irvine, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Irvine, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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